EX-99.1 2 dex991.htm PRESENTATION OF INDEVUS PHARMACEUTICALS, INC. PRESENTATION OF INDEVUS PHARMACEUTICALS, INC.
CIBC Annual Biotechnology & Specialty
Pharmaceuticals Conference
April 11, 2007
Exhibit 99.1


2
Safe Harbor Statement
This presentation contains “forward-looking statements”
as defined in the Private Securities Litigation
Reform Act of 1995. These statements are based on current expectations of future events. Such statements
include,
but
are
not
limited
to,
the
timing
of
completion
of
the
transaction
and
potential
purchase
accounting
charges. These statements are just predictions and are subject to risks and uncertainties that could cause
the actual events or results to differ materially. These risks and uncertainties include receipt of regulatory
and stockholder approval, integration of the two companies post-closing, market acceptance for the
transaction and approved products, management of rapid growth, risks of regulatory review and clinical
trials, intellectual property risks, and the need to acquire additional products. The reader is referred to the
documents that Indevus and Valera file from time to time with the Securities and Exchange Commission. 
Indevus and Valera do not undertake any obligation to publicly release the results of any revisions that may
be made to any forward-looking statements to reflect the occurrence of anticipated or unanticipated events
or circumstances after the date of such statements.


3
Indevus Pharmaceuticals: An Emerging Leader in Urology
and Endocrinology
Indevus has established a commercial operation and late stage
pipeline focused on urology and endocrinology
Acquisition of Valera Pharmaceuticals is a perfect fit with the Indevus
corporate strategy of building a world class specialty pharmaceutical
company
Upon closing, the combined Company will have 3 marketed products
(one from Valera) and anticipates 5 product launches within 2 years
(2 in 2007 / 3 in 2008), including 3 from Valera
Fully leverages Indevus’
national sales force
Expected to be accretive within 2 years and significantly increase
EPS upon achievement of profitability


4
Indevus + Valera –
Product Pipeline
Building a Focused Portfolio of Products
CORE THERAPEUTIC AREAS
CORE THERAPEUTIC AREAS
Phase I     Phase II     Phase III        NDA
Market
Overactive bladder
SANCTURA XR
PRO 2000
Prevention of HIV
& other STDs
DELATESTRYL
®
Hypogonadism
NEBIDO
®
Hypogonadism
VANTAS
®
Prostate Cancer
SUPPRELIN
®
-LA
Central Precocious
Puberty
Overactive bladder
SANCTURA
®
VALSTAR
®
Bladder Cancer
Ureteral
Stent
Kidney Stones and
Other
Octreotide
Implant
Acromegaly
Indevus products in dark blue
Valera products in light blue


5
Indevus + Valera –
Product Pipeline
Partnered & Partnerable
Products
OTHER THERAPEUTIC AREAS
OTHER THERAPEUTIC AREAS
Preclinical   Phase I       Phase II      Phase III      Market
Pagoclone
Naltrexone
Implant
Drug Addiction
Hydron
Implant Tech
Stuttering
Serious fungal
infections
Aminocandin
PMDD
Sarafem
Other Uses
IP 751
Anti-inflammatory
Disorders
Indevus products in dark blue
Valera products in light blue
Licensed to Eli Lilly/Galen
Licensed to Novexel


6
Transaction Overview
Stock for Stock purchase of Valera Pharmaceuticals (VLRX)
$7.75 per share of Valera common stock with 10% collar
Deal Value ~ $120 Million + contingent payments
Contingent Payments in Indevus stock:
$1.00/share upon approval of SUPPRELIN
®
-LA and sufficient launch
quantities
$1.00/share upon approval of ureteral
stent
$1.50/share upon approval of octreotide
implant
Transaction expected to close on or about April 17, 2007


7
Product Portfolio
SANCTURA XR™
-
Overactive Bladder
Current Profile of SANCTURA
®
Only quaternary ammonium on the market
Low CNS side-effects
No clinically relevant metabolic drug-drug interactions
Excreted largely unchanged in the urine
Rapid onset of action
PLUS
Once-a-day dosing
Lower anti-cholinergic side effects
NDA Submitted –
October 2006
Two large Phase III trials with high-degree of efficacy
Landmark tolerability profile with 10.7% dry mouth rate
Target product launch –
2H 2007
U.S. OAB market in 2006: $1.5B (est.)


8
Product Portfolio
Co-Promotion Financial Terms with Esprit Pharma
Up Front and Approval Milestone
$150M
Phase III Initiation Milestone
$  10M
NDA Submission
$  10M
Future Milestones:
Approval
$35M
Commercialization (2013)
$20M
$125M+
20%
$  75 -
$125M
17.5%
$    0 -
$  75M
15%
Royalty Rates
Guaranteed Minimum Royalties
$10.5M
7/1/07-6/30/08
$  7.9M
7/1/06-6/30/07
$  5.6M
7/1/05-6/30/06
Esprit responsible for 100% of A&P expenses
Sales Force Subsidy:  $8.8MM per year
Co-promotion term:     December 2008


9
Product Portfolio
VANTAS
®
(histrelin
implant) -
Advanced Prostate Cancer
U.S. launch -
November 2004
Soft, flexible implant utilizing Hydron
Implant
Technology
12-month implant to deliver histrelin
(most
potent LHRH agonist) for the treatment of
advanced prostate cancer
Rapid sustained testosterone suppression
slows tumor growth
Total U.S. market for advanced prostate cancer
treatment > $600M
VANTAS
®
revenues for 2006:  $17.8M
Indevus has been co-promoting VANTAS with
85 additional sales representatives during Q1
2007


10
Product Portfolio
SUPPRELIN
®
-LA -
Central Precocious Puberty
12-month specifically formulated implant to deliver
histrelin
for the treatment of central precocious
puberty (CPP)
Provides consistent, reliable suppression for a 12-
month period
FDA Granted Orphan Drug Status in November
2005
Active agent previously approved for CPP
NDA submitted in June 2006
May 3, 2007 PDUFA date
Controlled diffusion
through implant wall


11
Valera Product Portfolio
SUPPRELIN
®
-LA -
Central Precocious Puberty
CPP is the early onset of puberty in young children
Incidence:
1
in
every
5,000
10,000
children
More common in female children
Patient age: typically under 9 years; as young as 4 years or less
Duration of therapy: 3 to 5 years or longer
U.S. prevalence: ~20,000 children
Treatment normally performed by pediatric endocrinologist
Hormonal suppression using LHRH agonist
Market dominated by single company
Approved leuprolide
depot suspension
Intramuscular injection
Administered to afflicted child every 3 to 4 weeks
Current price for Lupron
Depot-PED: $12,000 -
$15,000/yr


12
Product Portfolio
SUPPRELIN
®
-LA -
Market Opportunity
Market Research:  Ped
Endos
Implant conceptually attractive -
easier on families; less traumatic for kids
Steady 1-year hormonal suppression off-sets possible emotional “ups & downs”
associated with monthly injections
Expect improved compliance over multiple years of therapy; especially valuable for
younger patients who need up to 7 years of therapy
13 -
17 injections per year for 3 to 5 years
SUPPRELIN
®
-LA
Offer parents
a choice
This
Or


13
Product Portfolio
VALSTAR
®
(valrubicin) -
Bladder Cancer
Anthracycline
derivative of Doxorubicin solution for bladder
instillation
Current approved usage
29,000 BCG refractory patients per year (AUA est.)
15,000 –
not candidates for bladder removal
Valstar
®
is the only
approved product for these patients
FDA approved 1998
Product currently on FDA Drug Shortages List
Reformulation complete
Submission of supplemental NDA -
1H 2007
Possibility for other indications being explored


14
Product Portfolio
NEBIDO
®
-
Hypogonadism
Novel, long-acting preparation of testosterone undecanoate
First
and
ONLY
3-month
injection
Approved in over 80 countries
Phase
III
pharmacokinetic
study
complete
Q2
2007
Anticipated
NDA
submission
Summer
2007
Highly differentiable from existing therapies
U.S. market for testosterone replacement: $500M (est.)


15
Indevus Product Portfolio
NEBIDO
®
-
Hypogonadism
March 26
th
Trial Update
0% (0/103)
0% (0/97)
0%
% of Patients with C
max
> 2500ng/dl
0% (0/103)
4.1% (4/97)
<   5%
% of Patients with C
max
> 1800ng/dl
3.9% (4/103)
10.3% (10/97)
< 15%
% of Patients with C
max
> 1500ng/dl
~15%
~ 15%
Drop out rate
117 enrolled
120 enrolled
100
Patients
750mg/12week
1000mg/12 week
FDA
Guidelines


16
Product Portfolio
PRO 2000 -
Prevention of Sexual Transmission of HIV
Topical vaginal microbicide blocks pathogen entry into
susceptible cells
Active against a wide range of HIV isolates, chlamydia, herpes
and gonorrhea
Significant interest in female-controlled option
>$100M in designated funding by NIH and MRC
NIH Phase II/III trial –
3,200 women (on-going)
Enrollment completion expected by end of Summer
MRC Phase III trial –
10,000 women (on-going)
Enrollment completion expected first half of 2008
Multiple DSMB reviews already conducted
Large market opportunity
Traditional pharmaceutical pricing in U.S./Europe
Commodity pricing in developing world


17
Product Portfolio
Octreotide
Implant -
Acromegaly
6 month octreotide
(somatostatin
analog) implant to treat
acromegaly
Acromegaly: a chronic hormonal disorder
Excessive growth hormone & abnormal physical features
Higher incidence of diabetes & cardiovascular disease
Current
therapy:
Sandostatin
®
Daily or Monthly injections
2005 Worldwide Sales –
$900 million
U.S. sales for acromegaly
$200 million


18
Product Portfolio
Octreotide
Implant -
Acromegaly
Approximately 1,000 new acromegaly
patients per year
Treated by endocrinologists
Completed
Phase
I/II
study
demonstrating
significant
suppression
of
growth hormone and IGF-1 levels for 6 months
Phase II study on-going
Phase III trial to begin late 2007 / early 2008
Primary endpoint -
suppression of growth hormone and IGF-1 levels at
1 month
Studies designed to follow patients for 7 months


19
Product Portfolio
Biodegradable Ureteral
Stent
Presently,
conventional
non-biodegradable
stents
are
inserted
into
the
ureter
to
allow
urine
to
drain
when
the
flow
of
urine
may
be
obstructed
Approximately
1.2
million
procedures
per
year
for
the
removal
of
kidney
stones
in
U.S.
Estimated
800,000
ureteral
stents
used
per
year
Vast
majority
of
kidney
stone
removals
are
done
by
urologists
Currently
available
ureteral
stents
require
physician
intervention
for
removal
from
the
body
Biodegradable
stent
offers
multiple
potential
advantages:
Patient
comfort
Single
procedure
no
need
for
retrieval
Lack
of
encrustation
Considered
highly
desirable
by
urology
consultants
Device
application
(510k)
may
be
submitted
by
end
of
2007


20
Product Portfolio
Pagoclone -
Persistent Stuttering
Over 3 million patients in the U.S. with persistent stuttering
Novel, selective GABA-A receptor agonist
Complete toxicology, pharmacology and manufacturing packages for
NDA with more than 1,000 patients studied in previous anxiety trials
Successful
Phase
II
trial
completed
May
2006
Phase
III
to
include
adult
and
pediatric
studies
SPA
discussions
on-going
Fixed-dose response trials
6-month duration
Quantitative and qualitative primary and secondary endpoints
Worldwide rights to compound


21
Financial Highlights
Combined Company –
pro forma
$72.6 million in LTM revenues
$87.4 million in Cash (12/31/06)
Acquisition expected to be accretive within 2 years
Identified synergies of approximately $5.0 million per year
Valera
14.9 million shares outstanding
$18.0 million in LTM revenues
$13.9 million in LTM Net Loss
$14.1 million in Cash (12/31/06)
No Debt


22
2007 Milestones
Begin VANTAS
®
co-promotion
NEBIDO interim results reported
SUPPRELIN
®
-LA approval and launch
VALSTAR
®
supplemental NDA submission
NEBIDO
®
NDA submission
SANCTURA XR™
approval and launch
Octreotide
Implant Phase II results
Biodegradable Ureteral
Stent
510k submission


23
Additional Merger Information and Where to Find It
In
connection
with
the
merger
between
Indevus
and
Valera,
Indevus
filed
a
registration
statement
on
Form
S-4
with
the
SEC,
containing
a
joint
proxy
statement/prospectus
and
other
relevant
materials.
Such
joint
proxy
statement/prospectus
is
not
an
offer
to
sell
and
is
not
soliciting
an
offer
to
buy
these
securities
in
any
jurisdiction
where
the
offer
or
sale
is
not
permitted.
This
final
joint
proxy
statement/prospectus
was
mailed
on
or
about
March
14,
2007
to
the
stockholders
of
Indevus
and
Valera.
INVESTORS
AND
SECURITY
HOLDERS
OF
INDEVUS
AND
VALERA
ARE
URGED
TO
READ
THE
JOINT
PROXY
STATEMENT/PROSPECTUS
AND
THE
OTHER
RELEVANT
MATERIALS
BECAUSE
THEY
WILL
CONTAIN
IMPORTANT
INFORMATION
ABOUT
INDEVUS,
VALERA
AND
THE
MERGER.
The
registration
statement
and
joint
proxy
statement/prospectus
and
other
relevant
materials
including
supplements
and
amendments
(when
they
become
available),
and
any
other
documents
filed
by
Indevus
or
Valera
with
the
SEC,
may
be
obtained
free
of
charge
at
the
SEC’s
web
site
at:
http://www.sec.gov.
In
addition,
investors
and
security
holders
may
obtain
free
copies
of
the
documents
(when
they
are
available)
filed
with
the
SEC
by
Indevus
by
directing
a
request
to:
Indevus
Pharmaceuticals,
Inc.,
33
Hayden
Avenue,
Lexington,
MA
02421-7966,
Attn:
Investor
Relations.
Investors
and
security
holders
may
obtain
free
copies
of
the
documents
filed
with
the
SEC
by
Valera
by
contacting
Valera
Pharmaceuticals,
Inc.,
7
Clarke
Drive,
Cranbury,
NJ
08512,
Attn:
Investor
Relations.
Participants in the Merger Solicitation
Indevus,
Valera
and
their
respective
executive
officers
and
directors
may
be
deemed
to
be
participants
in
the
solicitation
of
proxies
from
the
stockholders
of
Indevus
and
Valera
in
favor
of
the
merger.
Information
about
the
executive
offers
and
directors
of
Indevus
and
their
ownership
of
Indevus
common
stock
is
set
forth
in
Indevus’
Annual
Report
on
Form
10-K
for
the
year
ended
September
30,
2006,
which
was
filed
with
the
SEC
on
December
7,
2006,
as
amended
by
the
Annual
Repot
on
Form
10-K/A
filed
with
the
SEC
on
January
26,
2007,
and
the
joint
proxy
statement/prospectus
for
Indevus’
2007
Annual
and
Special
Meeting
of
Stockholders,
which
was
filed
with
the
SEC
on
March
13,
2007.
Information
regarding
Valera’s
director
and
executive
officers
and
their
ownership
of
Valera
common
stock
is
set
forth
in
Valera’s
Annual
Report
on
Form
10-K
for
the
year
ended
December
31,
2006,
which
was
filed
with
the
SEC
on
February
22,
2007,
and
the
joint
proxy
statement/prospectus
for
Valera’s
2007
Special
Meeting
of
Stockholders,
which
was
filed
with
the
SEC
on
March
13,
2007.